Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors

• Status: Completed
• Trial end date: 2016-07-27
• Target enrollment: 0
• Participant gender: Male

Summary

This is an open label, single arm, single center, phase 2 study with the use of the antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell tumors who are not cured following first or subsequent chemotherapy lines for metastatic disease, followed by eventual surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborator: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Male gender.

• Confirmation of GCT histology based on pathologic review at Fondazione INT Milan.

• Unequivocal progression of measurable disease.

• A minimum of 2 and a maximum of 3 platinum-based chemotherapy lines for metastatic disease.

• First-line therapy should consist of at least 3 cycles of cisplatin-based chemotherapy.

• Prior single, tandem or triple high-dose chemotherapy course given as front-line or salvage therapy is allowed.

Exclusion Criteria:

• Failure to meet any of the above inclusion criteria.

• Concurrent treatment with other cytotoxic drugs or targeted therapies.

• Prior radiation therapy within 14 days of trial start.